UNSEALED LILLY-PRODUCED ZYPREXA DOCUMENTS

  1. Jan. 2003 e-mail corres. between Dr. John Buse of UNC School of Medicine and Eli Lilly in re manuscript related to the association between schizophrenia, diabetes and the use of antipsychotics
  2. Primary Care Implementation Guide for launch of expanding the market for Zyprexa with the primary care message of Zyprexa as a safe, proven solution
  3. Olanzapine: Implications for the Primary Care Physician Treating the Symptoms of Bipolar Mania and Schizophrenia; dated June 2001
  4. Therapeutic Class Review Olanzapine Heavyweight Team Agenda
  5. Record of Risk Profile Reviews and Updates
  6. Draft Copy: "Olanzapine: A Review of its Pharmacological Properties and Therapeutic Efficacy in the Management of Schizophrenia" with notes from Charles Beasley
  7. notes from Charles Beasley in re draft copy of "Olanzapine: A Review of its Pharmacological Properties and Therapeutic Efficacy in the Management of Schizophrenia"
  8. Final Report: Olanzapine in Humans; 1993
  9. Establish Olanzapine as THE Standard of Care
  10. Health Economics Olanzapine Overall Plans; 1996
  11. Aug. 1999 corres from FDA to Eli Lilly in re: "Olanzapine Versus Placebo in the Prevention of Relapse in Bipolar Disorder"
  12. Clinical Study Report F1D-MC-HGAD
  13. July 2000 corres from Eli Lilly to FDA in re: providing requested information with olanzapine
  14. Hyperglycemia Regulatory Response, Sec 1.1 to 1.34
  15. Phase I Historical Data
  16. Hyperglycemia Regulatory Response, Sec. 9
  17. Feb. 2000 corres from the European Agency for the Evaluation of Medicinal Products to Eli Lilly
  18. May 1999 e-mail from Dr. Bruce Kinon to Eli Lilly in re Pediatric Olanzapine Proposal
  19. Feb. 2000 Eli Lilly e-mail in re Multiple Messages
  20. Olanzapine: Other Clinical and Marketing Experiences
  21. Effect of Antipsychotic Therapy on Insulin Sensitivity: A Comparison of Olanzapine, Risperidone and Placebo in Normal Subjects
  22. Olanzapine: Implication for the Primary Care Physician Treating the Symptoms of Bipolar Mania and Schizophrenia
  23. May 2001 corres from Eli Lilly to FDA in re additional information pertaining to hyperglycemia
  24. Note to Reviewer from May 2001 corres from Eli Lilly to FDA in re additional information pertaining to hyperglycemia
  25. Note to Reviewers in re Meeting Request to discuss "proposed labeling based on a review of integrated safety data from seven clinical studies of olanzapine in elderly patients with dementia"
  26. J. Alan Webber summary of Feb 16, 1995 pre-NDA meeting with FDA
  27. Line Listing of Non-Alert Reports Quarterly Review Period Ending June 30, 1998
  28. Most Serious Adverse Events by Body System/IND Safety Reports
  29. Elderly PCP Sales Aid
  30. Current Zyprexa PCP Situation; Future Zyprexa PCP Opportunities; PCP Pilot Study
  31. Talking points for responding to FAQs about Olanzapine
  32. McKinsey work session on Olanzapine; Mar. 2001
  33. Meeting Preparation Document in re Oct. 2002 Glucose Dysreulation FDA Meeting
  34. Sales and Promotion Strategy in re types of physicians targeted
  35. Talking points for weight gain and Olanzapine questions
  36. Research Summary and Recommendations, First Quarter 2002, Zyprexa in Primary Care
  37. Hyperglycemia/Diabetes Data on Demand Resource Guide; Sept. 2001
  38. Primary Care for Patients with Behavioral, Mood, and Thought Disturbances; June 2001
  39. Partnering with Customers to Address Diabetes Concerns
  40. Hyperglycemia/Diabetes Data on Demand Resource Guide; Mar. 2001
  41. Zyprexa February Coaching Clinic Agenda; Feb. 2000
  42. Review of Commercially Marketed (Spontaneous) Hyperglycemia Adverse Event Reports and Olanzaine; Jan. 2000
  43. Handwritten notes from lunch meeting on Dec. 14, 1998 in re Lilly getting its message on weight gain and hyperglycemia
  44. Zyprexa Dosing Flexibility for on-label and off-label use
  45. Apr. 2001 e-mail corres from John Holcombe at Eli Lilly to Rury Holman requesting the writing of a section on the "mechanisms of action whereby drugs, in general, are known to cause altered glucose regulation," "vigilance when prescribing any antipsychotic," and "the need to put the risk/benefit ration into perspective."
  46. Feb. 2000 e-mail corres from Alan Breier to Zyprexa team in re Overview of Bipolar Labeling Meeting
  47. Feb. 2001 e-mail corres from Kerrie Mitchell to Michale Sale at Eli Lilly in re "supplements to psychiatry journals as part of the global counter strategy."
  48. Apr. 2001 e-mail corres from Alan Breier to Eli Lilly team in re Zyprexa publications and data mining
  49. Zyprexa Publications to 2000
  50. Mar. 2001 e-mail corres from Suni Keeling to Eli Lilly marketing in re "Managing Weight Gain and Hyperglycemia/Diabetes continue to be two of the top three priorities for Zyprexa in 2001."
  51. Mar. 2001 e-mail corres from Suni Keeling to Timothy Parshall in re very global and very strong reaction concerns about Zyprexa and diabetes and hyperglycemia
  52. Summary Table of Clinical Studies with Olanzapine
  53. Apr. communication from Eli Lilly to FDA in re labeling change in Japan
  54. Glucose Dysregulation Adverse Event Reports (Spontaneous) and Commercially Marketed Olanzapine in Japan; prepared for the FDA, April 2002
  55. Global Positioning Strategic Imperatives and Tactical Direction; June 2001
  56. Zyprexa U.S. Positioning Recommendation
  57. Bipolar Dashboard; Feb. 2001
  58. Jan. 2002 e-mail corres from Cassandra Mehlman of Zyprexa Brand Team to Eli Lilly team members in re "testing a new message element for psychs on how to diagnose, monitor and treate diabetes."
  59. Draft Copy with handwritten notes: Pharmacological Strategies for Using Atypical Antipsychotic Medications in Primary Care
  60. Zyprexa handout: Controlling crisis can lead to connection; dated 2001
  61. Eli Lilly Zyprexa Marketing Plan "to reach $6B by '06;" dated 2001
  62. Eli Lilly Zyprexa Marketing Plan "$6Billion by 2006;" dated 2002
  63. Zyprexa - Primary Care Physician Q&A; June 2002
  64. Eli Lilly Sales Representative Training Curriculum
  65. Eli Lilly Corporate Response Document pertaining to weight gain and diabetes
  66. Institutional Strategy and Message Backgrounder; Sept. 2003
  67. Retail Resource Guide; Sept. 2003
  68. Eli Lilly slide presentation on how to sell Zyprexa; dated 2001
  69. Health Outcomes and Economics: Issues in State Psychiatric Facilities; dated 2000
  70. Oct. 2000 e-mail corres from Mark Millikan Zyprexa Product Team to Masao Amano forwarding FDA document
  71. Update to Olanzapine and Glucose Homeostasis (prepared for FDA by Eli Lilly) June 2003
  72. Life Cycle Prioritization Project Regulatory Considerations High Dose and Borderline; Draft dated Nov. 2003
  73. Briefing Document Zyprexa (Olanzapine): Cognitive Impairment in Schizophrenia Pre-NDA Meeting; dated May 2002
  74. Feb 2002 e-mail corres from FDA to Lilly in re "analysis of treatment emergent diabetes"
  75. draft version of Olanzapine--Use in Children and Adolescents
  76. Oct. 2002 meeting between Eli Lilly and FDA
  77. Aug. - Sept. 2002 e-mail corres between Eli Lilly employees in re Israel, New Zealand and Austria's questions and actions concerning Zyprexa labeling and an op ed labeling Zyprexa's connection to diabetes "junk science"
  78. Oct. 2002 e-mail corres to Eli Lilly Zyprexa sales team in re Risperdal label change ordered by Health Canada and distinguishing Zyprexa from Risperdal
  79. Internal Report in re The Incidence of New Onset Diabetes and Use of Antipsychotics; dated June 2003
  80. Dec. 2003 letter from Eli Lilly to American Diabetes Association in re the presentation of Zyprexa and diabetes at the Consensus Development Conference on Antipsychotic Drugs and Diabetes
  81. July 2002 e-mail corres from Elizabeth Brummer to Eli Lilly Zyprexa Team in re Regulatory Request in Mexico concerning Hyperglycemia
  82. Oct. 2002 e-mail corres from Jared Kerr to Eli Lilly Zyprexa team in re additional comments to Cintrace section
  83. Jan. 2003 e-mail from Christopher Carlson to Eli Lilly Zyprexa team in re Decision on Diabetes Care submission and reviewer comments
  84. Nov. 2003 e-mail corres from Ludmila Kryzhanovskaya to Eli Lilly Zyprexa Team in re collecting fasting glucose and fasting lipid in olanzapine clinical trials as per the FDA request one year ago
  85. Olanzapine Labeling Change on Dementia for 14 jan 2004 GPLC - Chronology of Regulatory Correspondence Regarding Olanzapine and Cerebrovascular Adverse Events
  86. Mar. 2002 e-mail corres from Jared Kerr to Eli Lilly Zyprexa team in re "the Global Zyprexa Product Team does NOT agree with inclusion of Diabetes language in 'Precautions' or 'Warnings' section (not present at this time) of the Japan label."
  87. Eli Lilly plan of response to British Medical Journal finding "Olanzapine Increase the Risk of Diabetes"
  88. Feb. 2001 e-mail corres from Roland Powell to Eli Lilly Zyprexa team in re Lilly's response to Ziprasidon approval by FDA
  89. Addendum #2 Evaluation of Olanzapine and Cerebrovascular Adverse Events, Hypotension and Hyperglycemia and/or Weight Gain; dated June 2002
  90. Olanzapine - Screening and Monitoring For Metabolic Adverse Events
  91. May 2001 e-mail corres from Michele Sharp to Eli Lilly Zyprexa team in re documenting secondary endpoints of bipolar maintenance study to FDA
  92. Hyperglycemia/Diabetes Data on Demand Resource Guide 2001
  93. Atypical Antipsychotics Issues Management -- Hyperglycemia/Diabetes Data -- Lipid Data -- Published Literature/Posters Review; dated Oct. 2002
  94. Issue Strategy -- Problem Statement: "As a result of concerns about weight gain and fear of diabetes, an increasing number of physicians are either avoiding Zyprexa . . . Or switching longer term."
  95. issues Management: Faster Bolder More Visible: dated June 2003
  96. Draft: Project 180 Pilot Implementation; dated 2003 and addressing declining and flattening prescriptions
  97. Olanzapine Brand Council III -- Zyprexa US 2003-2004 Marketing and Business Plan; dated Aug. 2002
  98. Zyprexa Diabetes Strategy; Mar. 2002
  99. 1999 DTP Programs emphasizing Zyprexa's efficacy for depressive symptoms
  100. Partnering with Customers to Address Diabetes Concerns
  101. June 2003 e-mail corres between Eli Lilly Zyprexa team in re dealing with FAQs about Zyprexa and diabetes
  102. Mar. 2001 e-mail corres between Eli Lilly Zyprexa team in re Zyprexa and cardiovascular risk
  103. Sept. 2001 e-mail from Eli Lilly Japan to Eli Lilly Zyprexa team in re asking for instructions on a reported adverse event in Japan -- the Ketoacidosis related death of an individual taking Zyprexa
  104. Feb. 2000 e-mail corres from Peter Clark to Eli Lilly Zyprexa team in re minutes of meeting and reports on Zyprexa efficacy, CV, EPS, Prolactin, Relapse, Ziprasidone, health outcomes and weight change
  105. Jan. 2003 e-mail corres from Eli Lilly in Japan in re Eli Lilly's position on Zyprexa and diabetes and possible labeling about diabetes in Japan
  106. Dec. 2001 e-mail corres between Dr. Robert C. Smith of NYU Med Center and Eli Lilly Zyprexa team in re the proposed Lilly ITT: Comparative Effects of Chronic Treatment with Olanzapine and Other Atypical Antipsychotics on Glucose and Lipid Metabolism
  107. May 2002 e-mail corres from Robert S. Graham and Eli Lilly Zyprexa team in re messaging to primary care physicians
  108. July 2003 e-mail corres between Dr. Alan Breier of Eli Lilly and Dr. Douglas Berv of Yale University in re Zyprexa and increases in FB, lipids and weight
  109. Rapporteur's and Co-Rapporteur's Joint Response Assessment Report: Responses to CPMP request for supplementary information -- Zyprexa
  110. Sept. 2002 e-mail corres between Eli Lilly Zyprexa team in re publication in Am J Health Syst Pharmacists on relationship to hyperglycemia and hyperinsulinemia of antipsychotics.
  111. Partnering with Customers to Address Diabetes Concerns
  112. draft of Olanzapine - Use in Children and Adolescents with edits
  113. Brand Equity Tracking - Wave Two Survey Findings
  114. Directions for the promotion and sampling of Lilly products within Pediatric offices
  115. J. Buse, et. al., Journal of Clinical Epidemiology, 2003 "A retrospective cohort study of diabetes mellitus and antipsychotic treatment in the United States"
  116. Zyprexa Product Team Summary - July 2001
  117. Aug. 2004 corres from Myrna Weissman of Columbia University College of Physicians & Surgeon and Eli Lilly in re A Proposal to Eli Lilly & Company - Characteristics of Bipolar Depression in Primary Care with the proposal attached
  118. Viva Zyprexa Launch Meeting slide presentation
  119. Eli Lilly promotional brochure in re "Donna" profile
  120. Zyprexa Primary Care 2002 Marketin Plan
  121. graphs of Zyprexa percentage of the market over several variables from mid-2001 to mid-2002
  122. Zyprexa Olanzapine Brand Council III - - Zyprexa U.S. 2003-2004 -- Marketing and Business Plan; dated Aug. 2002
  123. Abilify Deep Dive - - alignment session to differentiate Zyprexa from Ability; dated Feb. 2004
  124. Eli Lilly tracking of Zyprexa Marketing Message
  125. Performance Summary; dated Jan. 2000
  126. 2003-2004 Zyprexa U.S. Marketing Plan
  127. Zyprexa One Team Meeting in re bipolar message for B2B customers and blunting the Zeldox message, Mar. 2000
  128. Market Research Master Plan - - Zyprexa and the PCP Market
  129. Neuroscience Business Unit Financial Review: Feb. 2003
  130. July-Aug. 2001 e-mail corres in re formulating Zyprexa call plan
  131. May 2003 e-mail corres in re request from Jeff McCombs at USC to use the Lilly Medi-Cal data for competitor's research
  132. Mar. 2003 e-mail corres between Jeff McCombs at USC and Lilly in re prioritizing research on Lilly funded projects
  133. Dec. 2002 e-mail corres between Jeff McCombs at USC and Lilly in re Medical formulary
  134. Dec. 2002 e-mail corres between Eli Lilly Zyprexa team in re Looking Ahead to 2003 - Threats to Equal and Unrestricted Access
  135. Spreadsheet of Research Options/Projects and their budget for prioritization: 2000-2002
  136. Oct. 2003 e-mail corres between Dr. John Buse and Eli Lilly in re submission for publication in British Journal of Psychiatry "Retrospective Analysis of Risk Factors in Patients with Treatment-Emergent Diabetes during Clinical Trials of Antipsychotic Medications"
  137. Briefing Document prepared by Eli Lilly for FDA in advance of Oct. 2002 meeting to discuss additional data regarding atypical antipsychotics and glucose metabolism/deregulation
  138. Jan. 2003 - Feb. 2003 e-mail corres between Eli Lilly Zyprexa team in re driving TMAP implementation
  139. Zyprexa Product Team 4 Column Summary
  140. Instructions to U.S. Sales Organization in re background and verbatim answers concerning FDA Notification of Class Labeling for Atypical Antipsychotics Regarding Hyperglycemia and Diabetes
  141. Zyprexa Primary Care -- Selected Objections and FAQ responses
  142. July 2002 Dear Doctor letter from Caremark in re Zyprexa's benefits and comparable risks
  143. Plan for preparing the market for the launch of intramuscular olanzapine and filling in the droperidol gap
  144. Strategies and Programs for marketing Zyprexa globally
  145. Economic Value of Olanzapine; dated Sept. 2004
  146. Plan for marketing in pediatrics
  147. Oct. 2002 communications between Eli Lilly and FDA in advance of meeting to discuss glucose deregulation
  148. Mar. 2003 e-mail corres between Eli Lilly Zyprexa team in re doctors voicing concerns about weight gain
 
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